Mumbai, Jun 3 (UNI) Pharma major Lupin on Wednesday said that it has has entered into distribution agreement with three companies for its orphan drug NaMuscla (mexiletine).

Exeltis Healthcare SL, Cresco Pharma BV and Macure Pharma Apps will commercialise NaMuscla® for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders in certain EU territories.

NaMuscula is the first and only licensed product for this indication,company said in a filing with BSE.

NDM disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. NaMuscla® reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional and clinical outcomes1. NaMuscla®, which has been designated orphan drug status, received EU marketing authorization in December 2018.

Under the agreements announced today, Exeltis Healthcare S.L will commercialize NaMuscla in Spain and Portugal, Cresco Pharma B.V will commercialize NaMuscla® in the Netherlands and Macure Pharma ApS in the Nordic countries. Lupin will continue commercialization of NaMuscla® in Germany and UK and will launch the product in Austria and France later this year.

"These distribution agreements represent an important milestone for Lupin as we roll out commercialization of NaMuscla across Europe. Collaborating with partners that are highly effective in their focus territories ensures patients will receive the drug in as effective manner as possible," said Thierry Volle, President EMEA, Lupin.

"Lupin is committed to addressing the unmet needs of patients with NDM through the establishment of country-specific solutions and to ensuring patient access across Europe in alignment with national health authorities, healthcare providers and patient advocacy groups."he added.

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